,i  #aagth ,,congress  #b;d ,session    
,h4 ,r4 #fgjb  ,,in ,,the ,,house ,,of  
,,representatives  ,february #i1        
#bjbb,mrs4 ,walorski 7for herself1 ,mr4 
,mc,kinley1 ,mr4 ,long1 ,mr4 ,duncan1   
,mr4 ,banks1 ,mr4 ,mooney1 ,mr4         
,lamborn1 ,mr4 ,curtis1 ,mr4 ,hudson1   
,mr4 ,ellzey1 ,mr4 ,babin1 ,mrs4        
,miller-,meeks1 ,ms4 ,foxx1 ,mr4        
,burchett1 ,mr4 ,burgess1 ,mr4          
,feenstra1 ,mr4 ,joyce of ,pennsylvania1
 ,mr4 ,la,malfa1 ,mr4 ,c4 ,scott        
,franklin of ,florida1 ,mrs4 ,fischbach1
 and ,mr4 ,luetkemeyer7 introduced the  
following bill2 which was referred to   
the ,committee on ,energy and ,commerce 
,a ,,bill  ,to require more accurate    
reporting of abortion drug prescribing  
and related adverse events1 and for     
other purposes4  #a4 ,short title ,this 
,act may be cited as the ,safeguarding  
,women's and ,children's ,health ,act of
 #bjbb4  #b4 ,findings ,the ,congress   
finds the following3 7#a7 ,many data    
limitations affect the accuracy of      

statistics related to chemical abortions
 in the ,united ,states1 and there is no
 central database tracking this         
information4  7#b7 ,states may          
voluntarily choose to share abortion    
data with the ,centers for ,disease     
,control and ,prevention 7,,cdc71 but   
the ,guttmacher ,institute1 which       
directly surveys abortion providers1    
consistently documents #cj to #dj       
percent more abortions than the ,,cdc4  
7#c7 ,some ,states with high volumes of 
abortion1 such as ,california1 do not   
report to the ,,cdc4  7#d7 ,only #bh    
,states require abortion providers to   
report complications1 but there is      
rarely an enforced penalty for          
noncompliance4 ,only #ab ,states require
 other physicians1 coroners1 or         
emergency rooms to report complications 
or deaths for investigation1 and        
frequently these facilities and         
physicians are unaware of these         
reporting requirements4  7#e7 ,these    
data problems are a significant         

limitation to ,united ,states studies on
 abortion complications4  7#f7 ,women   
experiencing complications will often   
present to an emergency room rather than
 return to the abortion provider1 and   
researchers frequently ignore the       
difficulty in obtaining accurate        
,international ,classification of       
,diseases coding in emergency rooms due 
to search engine failure to discover    
induced abortion codes1 which leads to  
miscoding and frequently attributing    
induced abortion complications to       
spontaneous abortions4  7#g7 ,when      
compared to surgical abortions1 chemical
 abortions are over #ej percent more    
likely to result in an abortion-related 
visit to an emergency room1 and by      
#bjae1 #fj percent of chemical          
abortion-related emergency room visits  
were incorrectly coded as miscarriages4 
7#h7 ,better quality1 international     
records-linkages studies1 and           
meta-analyses document far higher rates 
of complications and mortality from     

abortion1 casting doubt on the validity 
of the reported data by which ,united   
,states public health decisions are     
made4  7#i7 ,independent systematic     
analysis of adverse event reports       
submitted to the ,food and ,drug        
,administration 7,,fda7 between #bjjj   
and #bjai revealed approximately #c1jjj 
,united ,states adverse events out of an
 expected #ahe1jjj adverse events based 
on the known and published complication 
rate after mifepristone misoprostol     
abortions4 ,thus1 the ,adverse ,event   
,reporting ,system of the ,,fda captured
 only #a4g percent of the actual adverse
 events occurring in ,united ,states    
women1 the majority of which occurred   
prior to #bjaf when mifepristone        
prescribers were required to report     
adverse events as part of the risk      
evaluation and mitigation strategy4     
7#aj7 ,in #bjaf1 the ,,fda relaxed the  
gestational age dispensing from a       
limitation of #g weeks gestation to a   
limitation of #aj weeks gestation1 and  

at the same time the ,,fda no longer    
required mifepristone prescribers to    
report adverse events other than death4 
,these simultaneous changes ensured that
 there would be no way to capture the   
increased adverse events resulting from 
the relaxation of the gestational age   
requirements4  7#aa7 ,in order to fulfil
 the statutory requirement of the ,,fda 
to oversee and evaluate the safety of   
mifepristone use as an abortifacient1   
substantial changes in the adverse event
 reporting for mifepristone must be     
implemented to obtain an accurate       
evaluation of the impact of             
mifepristone-related adverse events on  
,united ,states women4  #c4 ,accurate   
reporting on chemical abortion and      
related adverse events  7a7 ,reporting  
requirements ,the ,secretary of ,health 
and ,human ,services1 acting through the
 ,commissioner of ,food and ,drugs1     
shall require any abortion drug1        
including any abortion drug approved by 
the ,food and ,drug ,administration     

before the date of enactment of this    
,act1 to have a risk evaluation and     
mitigation strategy requiring that--    
7#a7 within #ae days of becoming aware  
of any death or other adverse event in a
 patient associated with the use of such
 abortion drug1 a health care provider  
shall-- 7,a7 report such death or       
adverse event to the ,food and ,drug    
,administration and to the manufacturer 
of such abortion drug2 and  7,b7        
identify in such reporting the patient  
by a nonidentifiable reference and the  
serial number from each package of such 
abortion drug if available2 and  7#b7 a 
health care practitioner who prescribes1
 dispenses1 or administers such abortion
 drug shall-- 7,a7 within #ae days of   
such prescribing1 dispensing1 or        
administering1 report the action to the 
,food and ,drug ,administration and the 
,centers for ,disease ,control and      
,prevention2 and  7,b7 exclude from such
 reporting any individually identifiable
 patient information4  7b7 ,portals ,the

 ,secretary of ,health and ,human       
,services1 acting through the           
,commissioner of ,food and ,drugs1      
shall-- 7#a7 establish and maintain an  
online portal that allows health care   
practitioners to easily1 confidentially1
 and securely report to the ,food and   
,drug ,administration and the ,centers  
for ,disease ,control and ,prevention by
 means of online transmission the       
information required by subsection 7a7  
to be reported2 and  7#b7 establish and 
maintain an online portal that allows   
patients to easily1 confidentially1 and 
securely self-report to the ,food and   
,drug ,administration and the ,centers  
for ,disease ,control and ,prevention by
 means of online transmission any       
adverse events the patients have        
experienced that are associated with use
 of an abortion drug4  7c7 ,definitions 
,in this section3 7#a7 ,the term        
abortion drug means any drug1 substance1
 or combination of drugs or substances  
that is intended for use or that is in  

fact used 7irrespective of how the      
product is labeled7-- 7,a7 to           
intentionally kill the unborn child of a
 woman known to be pregnant2 or  7,b7 to
 intentionally terminate the pregnancy  
of a woman known to be pregnant1 with an
 intention other than-- 7i7 to produce a
 live birth2  7ii7 to remove a dead     
unborn child2 or  7iii7 to treat an     
ectopic or molar pregnancy4  7#b7 ,the  
term adverse event means any untoward   
medical occurrence associated with the  
use of a drug in humans1 whether or not 
considered drug-related4  7#c7 ,the term
 unborn child means an individual       
organism of the species homo sapiens1   
beginning at fertilization1 until the   
point of being born alive as defined in 
section #h7;b7 of title #a1 ,united     
,states ,code4  #d4 ,improved reporting 
of data related to chemical abortions   
,the ,public ,health ,service ,act is   
amended by inserting after section      
#cag,u of such ,act 7#db ,u4,s4,c4      
#bdg;b-#bc7 the following3  #cag,v4     

,improved reporting of data related to  
chemical abortions  7a7 ,in general ,the
 ,secretary1 acting through the         
,director of the ,centers for ,disease  
,control and ,prevention1 shall-- 7#a7  
collect and aggregate in a standardized 
format information that is reported     
pursuant to section #c of the           
,safeguarding ,women's and ,children's  
,health ,act of #bjbb with respect to   
abortion drugs2  7#b7 make such         
information available in accordance with
 section #eeb of title #e1 ,united      
,states ,code2 and  7#c7 annually       
publish-- 7,a7 the number of abortion   
drugs prescribed in the ,united ,states2
  7,b7 the number of abortion drugs that
 are shipped directly to prescribers and
 to patients2  7,c7 the total number of 
deaths that occurred within #abj days of
 ingestion of an abortion drug1         
regardless of causal attribution1 and   
the cause of death2  7,d7 the total     
number of serious adverse events that   
occurred within #abj days of ingestion  

of an abortion drug2  7,e7 the number of
 times each such serious adverse event  
occurred2  7,f7 the total number of all 
adverse events that occurred within #abj
 days of ingestion of an abortion drug1 
stratified by the ,common ,terminology  
for ,coding ,adverse ,events 7or any    
successor publication7 criteria for     
severity grading2 and  7,g7 the number  
of times abortion drug ingestion        
resulted in an incomplete abortion4  7b7
 ,technical assistance ,the ,secretary  
shall provide technical assistance to   
facilitate and improve the reporting of 
data for purposes of this section4  7c7 
,annual reporting ,the ,secretary       
shall-- 7#a7 annually publish a report  
on the data collected and aggregated    
pursuant to subsection 7a77#a72 and     
7#b7 post such report on the public     
website of the ,food and ,drug          
,administration4  7d7 ,definitions ,in  
this section3 7#a7 ,the term abortion   
drug means any drug1 substance1 or      
combination of drugs or substances that 

is intended for use or that is in fact  
used 7irrespective of how the product is
 labeled7-- 7,a7 to intentionally kill  
the unborn child of a woman known to be 
pregnant2 or  7,b7 to intentionally     
terminate the pregnancy of a woman known
 to be pregnant1 with an intention other
 than-- 7i7 to produce a live birth2    
7ii7 to remove a dead unborn child2 or  
7iii7 to treat an ectopic or molar      
pregnancy4  7#b7 ,the term adverse event
 means any untoward medical occurrence  
associated with the use of a drug in    
humans1 whether or not considered       
drug-related4  7#c7 ,the term serious   
adverse event means an adverse event    
that meets ,common ,terminology for     
,coding ,adverse ,events criteria 7or   
any successor publication7 for level #c 
or above4  7#d7 ,the term unborn child  
means an individual organism of the     
species homo sapiens1 beginning at      
fertilization1 until the point of being 
born alive as defined in section #h7;b7 
of title #a1 ,united ,states ,code4  4